NCT05980195

Cognitive Improvement After Carotid Stenting in Hyperbaric Oxygen Therapy Trial

Cognitive Improvement After cARotid stEnting in HyperBaric Oxygen Therapy Trial (CARE-HBOT)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of CARE-HBOT study is to evaluate whether patients with symptomatic severe carotid artery stenosis with cognitive impairment who underwent hyperbaric oxygen therapy plus standard medical treatment after stent implantation could improve their cognitive function compared with those who underwent standard postoperative medical treatment.

Detailed description

This study is a prospective, multi-center, 1:1 randomized trial. In patients with symptomatic severe carotid artery stenosis with cognitive impairment underwent stent implantation, whether hyperbaric oxygen therapy plus standard medical treatment after stenting could improve their cognitive function compared with those who underwent standard postoperative medical treatment will be studied. Primary endpoint: Cognitive level at 6 months of follow up.

Conditions

• Carotid Stenosis
• Cognitive Impairment
• Hyperbaric Oxygen Therapy
• Stent Implantation

Interventions

Type	Name	Description
PROCEDURE	Hyperbaric oxygen therapy	Hyperbaric oxygen therapy for 30 times within 50 days
DRUG	Standard medical treatment	Standard medical treatment consists of dual antiplatelet treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 per day mg, or ticagrelor 90 mg twice per day for 3 months after stenting). Other Name: Dual antiplatelet therapy for 3 months
BEHAVIORAL	Risk factor management	Management of risk factors including hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise

Timeline

• Start date: 2024-07-16
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-08-07
• Last updated: 2024-07-18